Phase III trial-pembrolizumab or brentuximab vedotin-Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma
IRAS ID
203703
Contact name
Kirit Ardeshna
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2015-005053-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
years, 74 months, 1 days
Research summary
Hodgkin lymphoma (HL) accounts for approximately 10% of all lymphomas and 0.6% of all cancers diagnosed annually in the developed world.
Combination chemotherapy and radiation therapy of originally involved lymph nodes, have substantially improved the prognosis of patients with HL. However, the prognosis is very poor for patients who relapse or have progressive disease (PD) after autologous stem-cell transplantation (auto-SCT) and for patients who have cancer which does not respond to standard treatment. Novel agents with different mechanisms of action have demonstrated a certain level of activity, brentuximab vedotin being the most active. However, better improved therapies are needed and no standard of care is currently available for patients with PD after brentuximab vedotin, representing an urgent unmet medical need.
Programmed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug pembrolizumab is a potent and highly selective humanized monoclonal antibody developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
The purpose of this phase III study which will last approximately 40 months is to evaluate the safety and efficacy of pembrolizumab versus brentuximab vedotin assessing Progression Free Survival (PFS) and Overall Survival (OS).
Approximately 300 male/females adults older than 18 with relapsed or refractory classical HL will be randomised at a 1:1 ratio to receive pembrolizumab 200 mg intravenous (IV) every 3 weeks or brentuximab vedotin 1.8mg/kg IV every 3 weeks.
The study is funded by Merck Sharp & Dohme Limited and will take place at 6 study centres in the UK.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0291
Date of REC Opinion
13 Oct 2017
REC opinion
Further Information Favourable Opinion